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Apart from clinical evaluation, the patients need to be closely assessed by various laboratory parameters to monitor the improvement on treatment, drug-induced adverse events or co-morbidities to enable timely interventions to address these and improve the probability of treatment success, survival and quality of life.

 

Table: Laboratory evaluations and follow-up schedule for patients on shorter oral Bdq containing Multidrug-resistant (MDR)/ Rifampicin-resistant (RR) TB regimen; Source: Guidelines for PMDT in India 2021, p54.
EVALUATION TEST FOLLOW-UP SCHEDULE
Clinical + Weight (Wt.) Monthly in Intensive Phase (IP) or extended IP if the previous month shows Smear-positive (S+ve), quarterly in Continuation Phase (CP)
Smear Microscopy (SM)
  • Monthly from 3rd month onwards till end of IP 
  • Monthly in extended IP only if the previous month S+ve (IP extension up to a maximum of 6 months)
  • Conduct SM within 7 days, if the smear at 6 months is positive to rapidly ascertain bacteriological conversion/ reversion.
Culture
  • At the end of month 3, end of month 6 and/or end of treatment
  • If the culture result of month 6 is positive, collect one repeat sample immediately to rapidly ascertain the bacteriological conversion/ reversion. 
  • If the repeat sample is culture-negative, then end of treatment specimen collection should be done.

Drug Susceptibility Testing 

(DST)

First-line and Second-line Line Probe Assay (FL-SL LPA) (Levofloxacin (Lfx), Moxifloxacin (Mfx), Ethionamide (Eto)) and Liquid Culture and Drug Susceptibility Testing (LC&DST) (Pyrazinamide (Z), Bedaquiline (Bdq)*, Clofazimine (Cfz)*, Mfx, Linezolid (Lzd), Delamanid (Dlm)*) if any of the following: 

  • Culture +ve (end of month 3 or later and end of treatment) 
  • Smear +ve at end of IP, end of extended IP and end of treatment
Urine Pregnancy Test (UPT) As and when clinically indicated
Complete Blood Count (CBC) As and when clinically indicated
Thyroid Stimulating Hormone (TSH) and Liver Function Test (LFT)# At end of IP, then as and when clinically indicated
Chest X-ray (CXR) At end of IP, then as and when clinically indicated, end of treatment
Electrocardiogram (ECG)$ At 2 weeks, then monthly in the first 6 months, then as and when clinically indicated

Serum Electrolytes 

(Na, K, Mg, Ca)

 As and when indicated and in case of any QTcF prolongation
Specialist consultation As and when clinically indicated
Colour vision test Once in two months (in children) 

# HBsAG and other viral markers (Hepatitis A, C & E) to be done in case of Jaundice.

 

$ In case of baseline ECG abnormality or QTcF ≥450ms with a shorter oral Bedaquiline-containing MDR/RR-TB regimen that contains Bdq and Cfz, ECG must be done on daily basis for initial 3 days or as suggested by a cardiologist. Repeat ECG with long II lead after an hour to reconfirm abnormal ECG. 

DST whenever available.

  

 

Important Points

  • The most important evidence of response to DR-TB treatment is the conversion of sputum smear and culture to negative. 
  • If no additional resistance is detected on follow-up after 3rd month, the IP will be extended on monthly basis up to a maximum of 6 months.

 

If bacteriological reversion is ascertained or if any resistance is detected by FL-LPA or SL-LPA or if found to be smear/ culture positive at the end of 6 months or later, the patient will be declared as ‘treatment failed’.

 

  • The patient is then re-evaluated for a longer oral Multi (M)/ Extensively Drug-resistant TB (XDR-TB) regimen with appropriate modification if required.
  • A patient once treated with the shorter oral Bedaquiline-containing MDR/RR-TB regimen for more than one month will never be reinitiated on it again.

 

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